Dukoral

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Recombinant cholera toxin B subunit 1mg; Vibrio cholerae Inaba 48 Classical biotype 31250 million organisms (heat inactivated); Vibrio cholerae Inaba 6973 El Tor biotype 31250 million organisms (formalin inactivated); Vibrio cholerae Ogawa 50 Classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated)

Dostopno od:

Seqirus (NZ) Ltd

INN (mednarodno ime):

Recombinant cholera toxin B subunit 1 mg

Farmacevtska oblika:

Oral suspension

Sestava:

Active: Recombinant cholera toxin B subunit 1mg Vibrio cholerae Inaba 48 Classical biotype 31250 million organisms (heat inactivated) Vibrio cholerae Inaba 6973 El Tor biotype 31250 million organisms (formalin inactivated) Vibrio cholerae Ogawa 50 Classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection Citric acid Raspberry flavour 52383 AP0551 Saccharin sodium Sodium bicarbonate Sodium carbonate Sodium citrate dihydrate Citric acid Raspberry flavour 52383 AP0551 Saccharin sodium Sodium bicarbonate Sodium carbonate Sodium citrate

Enote v paketu:

Combination pack, glass vial and sachet, 1 dose unit

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

Valneva Sweden AB

Terapevtske indikacije:

Active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. The vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

Povzetek izdelek:

Package - Contents - Shelf Life: Combination pack, glass vial and sachet - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, glass vial and sachet - 2 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Sachet, powder, from 13-01-2021 - 5.6 g -   - Sachet, granules, to 13-01-2021 - 5.6 g -   - Vial, glass, suspension - 3 mL -  

Datum dovoljenje:

2001-05-02

Navodilo za uporabo

NEW ZEALAND CONSUMER MEDICINE INFORMATION
Page 1 of 9
DUKORAL
®
ORAL INACTIVATED CHOLERA AND ETEC VACCINE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Dukoral
®
.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your
doctor has weighed the risks
of you or your child taking Dukoral
®
against the benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT IN A SAFE PLACE. You
may need to read it again.
WHAT DUKORAL
® IS USED FOR
Dukoral
®
is a vaccine used to help prevent:
1.
Cholera which is caused by bacteria called _Vibrio cholerae_
2.
travellers’ diarrhoea caused by a type of bacteria called
enterotoxigenic_ Escherichia _
_coli _(ETEC) bacteria.
Dukoral
®
is used to protect people who are travelling to an area where there is
a risk of
cholera or diarrhoea due to ETEC bacteria.
Travellers’ diarrhoea can have many causes. ETEC is only one cause.
Dukoral
®
will only
prevent travellers’ diarrhoea due to ETEC.
Ask your doctor if you have any questions about why this medicine has
been prescribed for
you.
This medicine is available only with a doctor's prescription, except
when sold in a pharmacy
by a registered pharmacist.
_HOW IT WORKS _
Dukoral
®
works by causing your body to produce its own protection against
cholera and ETEC
diarrhoea. It does this by making substances called antibodies in the
intestine wall, which
fight the cholera bacteria (_Vibrio cholerae_) and the cholera toxin.
Cholera toxin causes
NEW ZEALAND CONSUMER MEDICINE INFORMATION
Page 2 of 9
diarrhoea and is produced by the cholera bacteria. ETEC bacteria also
produce a toxin, which
is almost identical to the cholera toxin. The antibodies your body
makes to fight the cholera
toxin also fight the ETEC toxin. If a vaccinated person comes into
conta

Lastnosti izdelka

NEW ZEALAND DATA SHEET
Page 1 of 10
1
DUKORAL®
DUKORAL® is an oral vaccine containing heat-inactivated _Vibrio
cholerae _O1 Inaba classic strain,
formalin-inactivated _Vibrio cholerae _O1 Inaba El Tor strain,
heat-inactivated _Vibrio cholerae _O1
Ogawa classic strain, formalin-inactivated _Vibrio cholerae _O1 Ogawa
classic strain, and
recombinant _Vibrio cholerae _toxin B subunit.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
_ACTIVE INGREDIENTS _
-
A total of 1.25 x 10
11
bacteria of the following strains:
_Vibrio cholerae _O1 Inaba classic strain
heat
-
inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae _O1 Inaba El Tor strain
formalin
-
inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae _O1 Ogawa classic strain
formalin
-
inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae _O1 Ogawa classic strain
heat
-
inactivated
ca. 31.25 x 10
9
bacteria*
Recombinant cholera toxin B subunit
1mg
*bacterial count before inactivation
One dose contains approximately 1,200 mg sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
DUKORAL® is provided as a whitish oral liquid suspension (vaccine) in
a single-dose glass vial with
white to off-white effervescent powder (buffer), in an accompanying
sachet.
The vaccine suspension is filled to a volume of 3 mL in vials (type I
glass) with a rubber
stopper (bromobutyl rubber) and a screw cap.
DUKORAL® is available in the following pack size:
Single-dose carton: one vaccine vial and one sachet of effervescent
powder.
Two-dose carton: two vaccine vials and two sachets of effervescent
powder
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
_CHOLERA_: Active immunisation of adults and children _from 2 years of
age, _who will be visiting areas
with an ongoing or anticipated epidemic or who will be spending an
extended period of time in
areas in which cholera infection is a risk.
The vaccine should be considered for foreign aid workers and others
intending to visit or spend
an extended period of time in areas endemic or epidemic